Hand sanitizer production has ramped up during the COVID-19 pandemic, with chemical companies and traditional sanitizer industry organizations increasing capacity and companies from nontraditional industries entering the fold to support the increased demand. But with more and more products entering the market, as well as a close eye on the effectiveness of hand sanitizer in the face of communicable diseases, it’s vital to have an accurate assessment of ingredients to back up safety requirements and label claims.

The FDA has released guidelines in an attempt to monitor the quality and safety of hand sanitizer. There is also a continually updated list of dangerous hand sanitizers that have been identified as hazardous to human health. Hand sanitizer testing from a qualified laboratory will verify that your product is not only safe (and off that dangerous product list), but also effective by industry standards to keep people as healthy as possible when hand washing isn’t practical.

Hand Sanitizer Testing for Safety

Hand sanitizers are topical antimicrobial products that kill microorganisms chemically. As such, they are regulated by the FDA as drugs within a 1994 document called the “Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products,” or TFM. Any company that produces hand sanitizers should become familiar with the requirements to make sure your product is meeting industry standards for safety and effectiveness.

When testing hand sanitizer for safety, qualified testing labs take a look at the composition to make sure that there aren’t any ingredients that are known to be harmful to consumers. For example, some hand sanitizers contain 1-propanol, which can be toxic and life-threatening to humans. Methanol is another problematic contaminant that can be dangerous. Products that contain these and other unsafe ingredients are placed on the FDA’s list of dangerous hand sanitizers.

Using microbiology and ingredient analysis, hand sanitizer testing is able to identify potential safety issues before your product hits the shelf for consumers. In the case of a claim made against your company’s product, you can verify the ingredients meet the FDA guidelines for safety by running a series of reliable, third-party tests.

Biocidal Efficacy

Companies have been coming out of the woodwork to distribute hand sanitizer to consumers in light of a boom in demand. The increase in competition may be a factor for some legacy companies, while others are just getting into the market with a new product. Either way, quality is a top priority not only for the buyers who are hoping to keep safe but also for the companies that rely on consumer reputation and trust.

Not all sanitizers are created equal. Alcohol-based hand sanitizers can reduce microbes on hands in some cases, but the amount of alcohol in the formulation as well as the amount of product used will have an effect on the efficacy. The CDC recommends people use alcohol-based hand sanitizer with at least 60% ethanol (or ethyl alcohol) for best results.

According to the TFM, safety and efficacy testing may not be required for some hand sanitizers, depending on the active ingredient (for example, products with more than 60% ethanol may not require efficacy testing). However, hand sanitizer testing in this case would benefit you as a confirmation that your product’s formulation meets CDC recommendations.

Testing labs are able to analyze hand sanitizers based on their bactericidal, virucidal, and fungicidal performance. Mimicking real-life scenarios including the amount of time hand sanitizer is likely to stay on someone’s hands (about 30 seconds), the lab can study whether or not the product effectively kills off harmful microbes per FDA guidelines.

Confidence in a Testing Partner

Hand sanitizer testing is beneficial not only for you to have confidence that you’re producing and distributing a high-quality, safe product, but also to back you up in case you need to address a claim against your company. Verifying your hand sanitizer formulation and efficacy keeps you within the FDA guidelines and CDC recommendations and builds trust among consumers that rely on your product to keep them healthy.

Partnering with a qualified testing lab with a good reputation and experience is vital in order to have peace of mind that you’re getting accurate test results. Barrow-Agee has more than 100 years of experience in all kinds of testing, including microbiology and ingredient testing that will detail the safety and efficacy of hand sanitizer.

We work quickly and efficiently to get accurate results to you in less than a week. Performing more than 150,000 tests per year, our team handles each sample and testing requirement with precision and a service-oriented approach. Contact us today to talk through your needs.